JP2005517488A - Ultrasonic treatment and imaging of adipose tissue - Google Patents

Abstract

A system for the destruction of adipose tissue that utilizes high intensity focused ultrasound (HIFU) within a patient's body. The system includes a controller for data storage and manipulation and control of multiple elements. One element is a means for mapping the human body to establish 3D coordinate position data for existing adipose tissue. The controller can identify multiple adipose tissue locations on the human body and establish a protocol for adipose tissue destruction. A HIFU transducer with one or more piezoelectric elements (21) is used with at least one sensor, which provides feedback information to the controller for safe operation of the piezoelectric elements (21). To do. The sensor is electrically connected to the controller, and the controller provides essential treatment command information to one or more piezoelectric elements based on positioning information obtained from the three-dimensional coordinate position data.

Description

(Reference to related applications)
This application is a non-provisional application filed on Feb. 20, 2002, U.S. Application Serial No. 60 / 357,628 (Attorney Docket No. 021356-000100), the entire disclosure of which is Incorporated as reference.

(Background of the Invention)
1. Field of the Invention The present invention relates to a method and apparatus for excising human fat by ultrasonically disrupting cells.

  2. Description of the Background Art Adipose tissue (more commonly known as “fat”) is formed from cells containing stored lipids. Adipocytes are very large, ranging in diameter up to 120 microns. These are typically spherical, but can be polygonal due to mutual deformation. A single droplet of lipid occupies the majority of the cell volume. The cell's nucleus is displaced to one side by accumulated lipids, and the cytoplasm is reduced to a thin rim that makes up only about 14 times the total volume of the cell. Each cell is surrounded by delicate reticulated fibers. Capillaries are found in the corner spaces between the cells. Capillaries form a loose plexus throughout the lipid tissue. Adipose tissue looks like a delicate structure with a large polygonal network in cross section.

  Lipid tissue is often subdivided into small lobes by connective tissue septa. This compartmentalization (visible to the naked eye) is most apparent in areas where fat is subjected to pressure. In other areas, the connective tissue septum is thinner and the tissue leaf tissue is less obvious.

  Lipid tissue is widely distributed in subcutaneous tissue, but exhibits regional differences in quantity. These regional differences are affected by age and gender. In infants and young children, there is a continuous subcutaneous layer of fat, which has a fairly uniform thickness throughout the body. In adults, the fat layer is thinned in some areas, but persists in certain preferred sites and increases thicker. These sites differ in the two sexes and are responsible for the significant differences in male and female body morphology. In males, the first region is the region covering the neck and the seventh cervical spine, the subcutaneous region covering the deltoid and triceps, the lumbroscal region, and the buttocks. In females, subcutaneous fat is most abundant in the anterior neck, breast, hips, medial epichanteric region, and anterior aspect of the thigh. Few blood vessels pass through the subcutaneous fat into the overlying skin, which receives its nutrients through the subcutaneous plexus of the blood vessels above the fat layer.

  In addition to the above fat deposits, there is considerable accumulation in both sexes in the omentum, mesentery, and retroperitoneal area. All of the above regions easily give up their stored lipids during starvation. However, there are other areas of fat that do not throw away the fuel so easily stored. For example, the orbit, the major joints, the palms, and the adipose tissue of the soles of the foot do not appear to benefit the metabolism, but instead have a supporting or protective mechanical function. These areas decrease in size only after very long hunger.

  Excess adipose tissue (ie obesity) is not good for health. This is because it causes various health problems (both physical and psychological properties) in humans. Beyond psychological effects (eg, bad self-image), obesity typically represents heart disease, high blood pressure, osteoarthritis, bronchitis, hypertension, diabetes, deep Increases the risk of conditions such as venous thrombosis, pulmonary embolism, dilated serpentine veins, gallstones and hernias.

  Thus, there is a clear need for a method that can remove adipose tissue. Dietary habits or good dietary habits are effective to some extent but are not a long-term solution for most humans; these approaches are not effective in situations where undesirable fat deposition is localized to the body.

  Liposuction extracts adipose tissue from the body by purely mechanical means. If adipocytes are destroyed after puberty, the remaining fat cells attempt to compensate to some extent, but about 70% of the fat contained in the destroyed cells is never recovered by the body. Permanent removal of fat from the human body is highly desirable but very difficult to perform. However, liposuction is a highly invasive and potentially damaging procedure associated with long-term unpleasant recovery due to the resulting separation of the skin from the body. For that reason, liposuction is not practical for weight control therapy and can be a practical body remodeling only in a limited area.

  Electromedical methods and devices have been used in the past for various surgical and therapeutic procedures. For example, US Pat. No. 4,527,550 to Ruggera et al. Discloses a radio frequency diathermy device (including means for localizing the thermal focus). U.S. Pat. No. 4,397,313 to Vaguine discloses a microwave thermotherapy device (including means for creating a concave electromagnetic field for concentrating electromagnetic energy in a specific region of the body). German Patent No. 2,508,494 to Schultz et al., US Pat. No. 4,343,301 to Indech, and US Pat. No. 3,958,559 to Glenn et al., For example, focus on tumors in the body. The present invention relates to an ultrasonic device capable of applying the same.

  However, these above systems are used for adipose tissue removal. In fact, some systems recognize the need to avoid damage to adipose tissue or other tissue surrounding the tissue to be destroyed. See, for example, U.S. Pat. No. 3,958,559, column 1, lines 24-25; U.S. Pat. No. 4,397,313, column 2, lines 45-57. U.S. Pat. No. 4,601,296 to Yerushalmi (which describes that known devices can automatically control undesirable RF heating of healthy tissue in column 1, lines 30-46). See These devices monitor the temperature adjacent to the work site and respond to control the operation of the antenna and cooling system.

  U.S. Pat. No. 4,397,314 to Vaquine states that in column 1, line 54 to column 2, line 11, healthy tissue is heated less effectively than a tumor by a prior art hyperthermia system. Point out. This is because healthy tissue is characterized by a developed vascular network and normal vasodilation to heat, so that blood flow can increase, for example, by a factor of 3 after 5 minutes of heating. On the other hand, tumors are characterized by damaged vascular networks and blood flow that collapses during heating.

  US Pat. No. 4,441,486 to Pounds et al. Relates to ultrasonic hyperthermia. Although this patent recognizes the need to control the scope of thermal treatment, it points out that this is not a major problem with ultrasound, because ultrasound does not preferentially heat adipose tissue. Yes.

  It is understood that US Pat. No. 5,143,063 to Fellner relates to the treatment of adipose tissue using ultrasonic energy, or microwave or radio frequency. However, this patent does not consider imaging techniques that ensure that the treatment area is covered by treatment energy.

  It is understood that US Pat. No. 6,071,239 to Cribbs et al. Teaches a HIFU array used in a method for selectively destroying adipocytes. However, this patent does not reasonably teach the progress tracking and imaging of the treatment area.

  Fritzsche, “With FDA Approval and Reimbursement in Place, Hyperthermia is Fourth Major Anti-Cancer Weapon, 1994” The device is only effective when there is a low percentage of body fat.

  The disclosures of the above referenced patents and materials are incorporated herein by reference.

  Thus, the perception in the art that adipose tissue should not be inadvertently heated during hyperthermia, and adipose tissue, which is more effectively blood cooled than tumor tissue, inherently There is further recognition that during hyperthermia treatment with prior art systems intended for treatments such as tumors, it is unlikely that the damaging energy dose will be inadvertently received.

(Brief summary of the invention)
Accordingly, the present invention relates to sonication and imaging of adipose tissue in a manner that substantially eliminates one or more problems due to limitations and disadvantages of the related art.

The present invention relates to a system for the destruction of adipose tissue utilizing high intensity focused ultrasound (HIFU) in a patient body, the system comprising:
Controller for electrical storage of data and for controlling multiple system components;
Means for mapping a human body for establishing three-dimensional coordinate position data for the presence of adipose tissue in the human, wherein the controller identifies a plurality of adipose tissue positions on the human body. And establish a protocol for adipose tissue destruction;
A transducer assembly having one or more piezoelectric elements for emitting high intensity focused ultrasound and at least one sensor, wherein the sensor is configured to safely operate the one or more piezoelectric elements on the controller. Provide feedback information for
Here, the at least one sensor is electrically connected to the controller, and the controller has an essential treatment on the one or more piezoelectric elements based on the position information obtained from the three-dimensional coordinate position data. Provides instruction information.

  An advantage of the present invention is to provide a data acquisition system having a probe and a linear array ultrasound imaging system. A linear array optical camera is connected to the skin through a fiber optic faceplate. This linear array is composed of a plurality of full-color pixels. When the optical camera is scanned, the data acquisition system maps an image or “finger plate” of the skin. This fingerprint is used as a coordinate system for future data collection and processing.

  Another advantage of the present invention is to provide a transducer probe that is incorporated into a laser “mouse” type system that tracks the movement of the transducer. There is an optical sensor at each end of the transducer probe. Thus, it can sense not only assembly movement, but also rotation.

  Another advantage of the present invention is to provide a probe in the transducer that measures fat tissue boiling and cavitation, and fat thickness.

  Another advantage of the present invention is to provide the practitioner with a skin “fingerprint” that details the treatment area of the body.

  Additional features and advantages of the invention will be set forth in the description that follows, and in part will be obvious from the specification, or may be learned by practice of the invention. The objectives and other advantages of the invention will be realized and attained by the structure particularly pointed out in the written description and claims hereof as well as the appended drawings.

  In order to achieve these and other advantages, and in accordance with the purpose of the present invention, as embodied and broadly described, a high intensity focused ultrasound transducer includes a plurality of piezoelectric elements, Consists of connected Fresnel lenses, where the Fresnel lenses comprise at least two materials, where the transducer measures any cavitation, boiling and / or thickness of the fat layer A plurality of sensors is further provided.

  It should be understood that both the preceding general description and the following detailed description are exemplary and explanatory and are intended to provide further explanation of the claimed invention.

(Detailed description of the invention)
As noted above, it is advantageous to remove certain portions (or certain major portions) of subcutaneous adipose tissue for both cosmetic and basic health reasons. To this end, according to the principles of the present invention, a practitioner sets up a treatment plan when consulting with a patient. This treatment plan involves determining the thickness of the fat in the area where the fat is to be removed from within the body. The optimum position for fat removal is then automatically determined. In general, the fat located at the deepest level in the body is removed first.

  The practitioner then reviews the data and confirms that the fat layer is properly identified.

  The treatment plan is then stored in a computer and the practitioner applies a transducer that can generate a high intensity focused ultrasound (HIFU) beam to the patient.

  The practitioner then “paints” the area to be treated using a display containing a map of the treatment area. For example, the display may show red on a blue background, and red will change to yellow as the area is processed. The computer tracks the area to be treated, prevents overexposure to the HIFU beam, and prevents multiple ensonization. It is not necessary for the practitioner to paint any particular pattern. All that is required is to “paint” the area of interest completely. A combination of sensors on the transducer is used to identify overlapping areas and prevent damage. The practitioner continues to paint until there are no longer any red areas present on the display indicating that the procedure is complete.

  Reference will now be made in detail to the accompanying drawings.

  To develop a treatment plan, the patient's body is first mapped with a mapping device. This mapping device produces an ultra high resolution “photo” of the skin over the treatment area. This photograph allows records to be processed and retained and associated across multiple visits.

  This mapping system locates imperfections in the skin, i.e. tears, freckles, hair follicle patterns, etc., which are used as key points in all subsequent measurements and procedures. These imperfect positioning is determined from the high resolution color image. This high resolution image has a higher resolution than a standard high resolution video.

  As shown in FIG. 1, the mapping system includes a line scanning camera 11. This line scan camera images only along the line and has a very high resolution, for example, 4,096 pixels. The line scan camera is mounted on a track 12 that extends over the patient. This track may be a predetermined type of gantry that the line scanning camera and other elements of the mapping system traverse during use. Therefore, the line scanning camera 11 can go around the patient 13 lying on the table 14. During the mapping process, the patient sleeps on his back and then becomes prone. Using the line scan camera 11 on the track 12, two images can be created by continuously scanning a patient lying on his back and prone. For example, if the scanned area is 4,000 pixels and 18 inches, then each pixel represents 5 mils (200 lines / inch). In some embodiments, the image may be 6,000 pixels long.

  Once the body is mapped, the practitioner examines the area of the skin where fat is to be removed during the assessment process by scanning the body with a high resolution linear array ultrasound system. This linear array ultrasound system operates at approximately 7.5 MHz and measures the thickness of fat on the body. Fat thickness measurement allows the practitioner to mark a constant fat thickness profile on the skin.

  More specifically, the practitioner scans the treatment area of the body and scans the underlying fat deposit with 0.5, 1.0, 1.5, 2.0, 2.5, ... cm thickness. Depicts and marks dots on the skin where each fat thickness is identified with a different color ink. Connecting similar colored dots provides a constant fat thickness profile. At this point, the body is imaged.

  After the patient is imaged, the printer prints a long, high-resolution paper (referred to herein as a skin fingerprint) that contains a constant fat thickness contour. This is a working document.

  The physician then follows the contours of the treatment site using an ink pen, and electronically enters the coordinates of this outline into the computer record.

  A final skin fingerprint is then created that matches the shape of the target body, including the final constant fat contour. The graph given to the physician shows the minimum final fat thickness allowed versus the thickness measured at the beginning of the treatment plan. The final contour set that represents the target shape of the patient's body does not interfere with the information from this graph. A second set of contour lines is then entered into the print computer using an electronic pencil on the print. The computer then includes a series of skin fingerprints showing the contour lines and HIFU transducers to be used during each session, consistent with the target shape and maximum volume of fat that can be removed per session To print. Thus, this treatment plan is defined by treatment contour points for transducers of various focal lengths at a given treatment interval. This treatment plan is also consistent with the desired symmetry, removal of deep fat in front of superficial fat, and the minimum amount of fat required throughout the body.

  Once the treatment plan is determined, patient treatment begins. The treatment device comprises a HIFU system, in particular a system comprising a plurality of independently controlled beam transducer elements that can be focused at a treatment depth below the skin surface.

  The procedure begins by applying a HIHU transducer (consisting of a plurality of transducer elements) to the patient. Referring to FIG. 2, each transducer element 20 includes a piezoelectric element 21, a solid coupling element 27, air cooling (not shown), and a focusing lens (not shown). In an exemplary embodiment of the invention, referring now to FIG. 3, five transducer elements occupy a treatment depth comprising 0.35-3.5 cm. The five transducer elements have focal points of 0.5, 0.8, 1.2, 1.9 and 3.0 cm, which correspond to 12, 9, 7, 5,. Operates at 5 and 4 MHz frequencies. It should be noted that the transducer can include a different number of transducer elements.

  FIG. 4A shows a bottom view of a 1.2 cm focal length transducer 40. In another exemplary embodiment, the transducer comprises 16 transducer elements 41, which are offset to produce 16 beam paths 141 spaced 0.3 cm apart ( staggered). These beams are operated in two modes: a first mode that generates a hexagonal pattern of disrupted tissue (when viewed from above); and a second mode that generates a continuous path of disrupted tissue. obtain. However, it should be noted that the transducer can comprise various numbers of transducer elements. A single piezoelectric element can be used for the creation of a HIFU, or multiple style transducers.

  In one aspect of the invention, the HIFU transducer may comprise a plurality of independently movable HIFU transducer elements constructed of a matrix. Thus, each individual transducer element can move in an “orbit” type motion (similar motion limited to that of a “ball and socket” joint). With this orbital motion, the focal point of delamination can delineate an annular region in the tissue, thus imparting more energy to the tissue than is delivered when the individual transducers are fixed and immobile. The circles of treatment tissue created by this motion can be sized so as to overlap or not overlap each other. In one aspect of the invention, a transducer element is formed after a series of ultrasonic pulses, a pattern of treated (broken) tissue points is formed instead of a treated tissue circle pattern. Can be arranged and manipulated to obtain. Various mechanical means well known in the art can be used to drive and control the movement of the transducer element.

  During the procedure, transducer 40 is applied to the patient. The transducer 40 may be entirely within the treatment area, outside the treatment area, or partially within the treatment area at any particular time. A transducer 40 according to the principles of the present invention may be manually manipulated and moved over a two-dimensional surface treatment region of the skin or moved in one dimension by an articulating arm or another mechanical device. Alternatively, the converter can be operated using an automated system. Automated systems can operate the transducer while in contact with the skin, but the safety system must be designed to ensure patient safety. Each beam 141 (FIG. 4C) of transducer element 20 in transducer 40 can be selectively and independently activated only when the transducer element is in the transducer region. As shown in FIG. 2, selective actuation can be achieved by providing an optical fiber 21 that passes through the center of each of the transducer elements 20. The optical circuit 23 sends the two colors generated from the two different color LEDs 26a and 26b down to the optical fiber 21 along the optical signal 24a. The reflected light 24b is applied to separate photodetectors 25a and 25b. Based on the ratio of the reflected light signals at these two detectors, it can be determined whether the beam is within the treatment area.

  A light emitting diode (LED) (not shown) is attached to the top of the transducer across each beam. The LED receives its light intensity from the signal to the corresponding beam. Thus, the operator sees the transducer being dragged across the treatment boundary of the treatment area and the beam is “off” outside the treatment area and “on” inside the treatment area. You can confirm that.

  The HIFU transducer applies each predetermined amount of ultrasonic energy per unit distance moved (not per unit time) for each treatment area. Thus, if the transducer stops or moves slowly, the beam is cut. Each transducer includes a laser position sensor 42, similar to the sensor found in an optical computer mouse, used as a relative motion sensor to measure the relative motion of the transducer. The laser position sensor provides a signal that controls the duty cycle of each beam of the transducer element. An indicator is provided on the operator panel that indicates the percentage of the maximum allowable speed at which the speed of the transducer is dragged. If the transducer is dragged too fast, the operator warning lamp will light up.

  The HIFU transducer also includes cavitation 43 and sensors that detect adipose tissue boiling. Cavitation sensors and boiling sensors confirm that the system is operating correctly. The effect of each beam in the transducer is determined by ordering and separating the working beams at regular intervals. The combination of transducers and sensors in a single body is also referred to as a transducer assembly, avoiding confusion with only HIFU emitting treatment transducers or imaging transducers.

  The HIFU transducer further comprises an ultrasonic A trace sensor 45 that monitors the bottom of the fat layer within the treatment area. The bottom of the fat layer must be a safe distance below the effective bottom of the treatment area. Otherwise, the transducer element beam is turned off and a warning lamp on the operator panel is lit.

  The HIFU transducer includes 3 or 4 redundant measuring instruments and a safety system to avoid damage to skin, muscle or other organs. For example, when the HIFU redundancy moves, the position measured by the relative motion sensor 42 is correlated with the skin fingerprint and compared to this fingerprint to determine the position relative to the skin fingerprint. Probes 43 and 44 are attached and these probes measure the size and volume and distribution of damaged tissue. The other probe 45 keeps track of the fat thickness and compares it with that of the data file. This file is continuously updated to maintain high integrity data for each patient. This file also contains the treatment plan and actual data obtained from various sensor measurements. These sensors generally include passive imaging methods to keep track of the complex shape of the treatment area. A separate data overlay is provided to characterize the cavitation, boiling and heated tissue within the treatment area. All information is provided to the physician performing the treatment plan on a display that includes a fusion of the data collected from the sensors. If any discrepancies occur between the data stored on the computer and the data measured by the sensor, a safety shutdown occurs.

  FIG. 4B shows an alternative embodiment comprising one piezoelectric element instead of an array of 16 elements.

  Reference will now be made in detail to HIFU transducers in accordance with the principles of the present invention as illustrated in the accompanying drawings.

  As shown in FIG. 5A, a conventional HIFU transducer produces a beam having a tissue killing area 51a along the beam axis near the focal point 22 of the transducer element. If a conventional transducer element is set to produce maximum destruction, the killed area will be approximately 2 mm in diameter and 18 mm long. Many applications using fat breaking are when the fat layer 29 is substantially less than 18 mm thick. As shown in FIG. 5B, and in accordance with the principles of the present invention, the length of the killed area 51b is shortened using weaker power, shorter times, or using shorter focal length transducer elements. Thereby, the cell destruction rate decreases.

  In contrast to conventional transducers that use multiple beams to compensate for the reduction in cell destruction rate, transducers according to the principles of the present invention are mechanical modulators (typically formed from Fresnel lenses). Provided with a piezoelectric element. This mechanical modulator modulates the ultrasound generated by the piezoelectric generator and focuses it into a multi-beam. According to one embodiment of the present invention, the transducer beam is applied to the treatment area, resulting in broken adipocytes aligned in a hexagonal matrix pattern. Thus, the center-to-center spacing of the treatment area is located between about 0.5 mm and about 3.0 mm depending on the depth from the skin surface to avoid skin puckering. Short focus lens transducers cause wounds at sub-millimeter intervals in patients with multiple beams, and deep focus lens transducers have fewer beams. However, the transducer element in the above arrangement provides a smooth skin surface. A smooth skin surface is obtained by generating a beam of a three-dimensional spatial pattern. The focal point (the overlapping beam acts as a focal spot and has a sound intensity approximately as high as the focal point) is well isolated and the transducer can be scanned to produce finely spaced cells . By generating a beam with a three-dimensional spatial pattern, the translocation effect of the presence of a focal point near the skin surface, and thus skin fold formation, is avoided.

  In one aspect of the invention, the transducer system increases the effectiveness by illuminating two or more beams of different frequencies on the same spot. One beam operates with high efficiency to generate cavitation bubbles, and the second beam operates at a lower frequency. Similarly, the additional beam also operates at a different frequency. Lower frequency beams are less than optimal but take advantage of bubbles generated by high efficiency beams. Thus, during treatment, the absorption of ultrasound energy in the skin is lower than in single frequency transducers, and the rate of tissue destruction in fat is increased.

  The transducer elements in the HIFU transducer can be focused using a connecting plate formed of two materials that connects the transducer and the skin. The two materials have an acoustic impedance that matches the piezoelectric element to the skin. The two types of materials according to the principles of the present invention include aluminum and plastic.

  Focusing a transducer element to a single point is accomplished by creating an appropriate phase plane on the front face of the transducer. This phase shift can be achieved by keeping the sum of the two thicknesses constant and changing the relative thickness of the aluminum and plastic. Therefore, the connecting plate has a constant thickness. If another focal spot is desired, a different phase pattern is required.

  Multiple focal spots can be modeled by calculating the phase at each element, and the phase for focus 1 (P1) and point 2 (P2) can be achieved. If two sine waves of the same frequency but different phase and amplitude are added, the law states that the result is a sine wave of the same frequency and the same phase and amplitude that can be calculated from the two given phases and amplitudes. Exists. This resulting phase sine wave applied to each element produces two focal spots. This law can be extended to any number of focal spots.

  Using the above-described law, a phase function that is concentrated simultaneously at two or more points can be calculated. These points can be freely arranged (ie they do not have to be in a row or even the same distance from the transducer surface).

  Referring to the patterns shown in FIGS. 6 and 6A, these aforementioned points are arranged in a three-dimensional “sawtooth” pattern. By scanning and / or undulating the transducer, the resulting dead tissue pattern is a hexagonal pattern as shown in FIG. 6B. This dead tissue pattern is much finer than the focal spot spacing. This scheme maintains sufficient spacing of the beams so that they pass through the skin.

  A mechanical modulator 70 for a single focus is shown in FIG. The mechanical modulator 70 comprises an aluminum layer 71a connected to the piezoelectric layer and a plastic layer 71b connected to the first matching layer. At the position where the phase reaches 360 °, the phase is reset to 0 °. The mechanical modulator of FIG. 7 may mask some waves as shown in shaded area 7. This wave masking affects only a few percent of the total beam and therefore does not affect concentration. However, wave masking slightly reduces wave effects. To compensate for the reduced wave effect, the mechanical modulator is diced as shown in FIG. This dice formation actually creates an “acoustic pipe” that has similar effects during vibration as it does when an optical fiber is lit. The phase modulation is then defined at the mechanical modulator surface rather than the aluminum-plastic contact surface. Therefore, shadowing does not occur.

  In a two-component (aluminum-plastic) system as shown in FIG. 8, the ratio that produces the desired phase on its surface results in a reflected wave or reflected impedance returning to the transducer element. This creates “effect” variations across the surface of the transducer. In the two-component system, aluminum 81a is machined and then plastic 81b is cast and polished to be parallel to the back surface of the aluminum. This arrangement is then diced. The cut surface 82 is centered at ½ wavelength (12 mil at 10 MHz).

  Alternatively, a three component (aluminum-plastic (A) -plastic (B)) system can be designed that provides the appropriate output phase and reflection impedance simultaneously. This ternary system requires machining aluminum, casting and machining plastic (A), and then casting and polishing plastic (B). However, higher manufacturing costs are required to maintain resistance in a three-component system.

  In accordance with another embodiment of the present invention, as generally shown in FIGS. 15A and 15B, the transducer element 20 can include a single spherical piezoelectric material 21 made of a single crystalline piezoelectric ceramic, A solid plastic 151 is provided between the skin 28 and the piezoelectric material. Solid state plastic 151 has a curved surface that can concentrate the phase of the wave from the piezoelectric material to a single point. The transducer element 20 according to an embodiment of the present invention may be beneficially made using existing tools for piezoelectric materials and is delicate to its solid after the transducer element is made. Modifications can be made. More particularly, and referring to FIG. 16, the transducer element comprises a metal 161 having a lower coefficient of expansion than the piezoelectric ceramic 21. A back plate 163 having an antireflection thickness T is formed. The antireflection thickness T is nλ / 2 (where n is an arbitrary integer, and λ represents an ordinary wavelength). The vacuum 165 opens a small hole 164 so that the ceramic is pulled in place during assembly. O-ring 166 connects metal 161 to the vacuum when the vacuum is activated. The edge of the ceramic 21 is inserted into this metal. As the temperature increases, the ceramic is compressed. As shown in FIG. 17, a transducer element according to this aspect of the invention is cooled by cold air 171 and hot air 172 is expelled from the transducer element. Fins (not shown) can be attached to the ceramic back and housing to guide air flow and increase heat transfer.

  It is important to know the position of the HIFU probe. When the beam is switched on, it is essential that only fat is in the killed area. From a cosmetic point of view, it is important that the treatment is applied in a geometrically accurate manner.

  The coordinate system is preferably not fixed to the treatment room of the treatment bed or other treatment device. This is because the patient's position moves relative to these coordinates during any predetermined treatment visit according to the treatment plan. Even breathing can change special fat coordinates. The best reference is the patient's skin with subcutaneous fat attached.

  Thus, there are four levels of measurement required according to the principles of the present invention: 1) Determine the position from the reference point or reference line using relative motion sensors; 2) Count the grid lines placed on the skin 3) determine the position by using the grid with the position encoded in the grid; and 4) by using imperfections in the skin (ie, skin fingerprints) as a reference Determine the position.

  Determining the position of the transducer using relative motion sensors is aided by the placement of the grid in the patient's body. The transducer's relative motion sensor is placed at a known grid point and moved to another point to provide a reference. According to another exemplary embodiment, a “ball and socket” type relative motion sensor similar to a computer mouse having a mouse ball, but with a rotation sensor, causes the ball in the socket to rotate around the sensor. The degree (and therefore the degree to which the mouse moves) is determined and this can be used instead. Advantageously, the method includes using two major and transverse measurements using laser light provided at the tip, bottom, left and right positions of the HIFU transducer. The differential measurement can correspond to rotation. In accordance with another exemplary embodiment of the present invention, the laser position sensor can use a moving speckle pattern to detect motion, thereby eliminating the need for a grid.

  Alternatively, rather than maintaining position tracking only using the mouse-type relative motion sensor, a grid can be applied to the patient's skin. The grid is applied with a paint containing a dye that is sensitive to a particular frequency of certain laser light. Thus, a fiber optic sensor coupled to the transducer with respect to the skin is also used to count grid crossings. There are many ways to identify the X and Y coordinate grids using different lights, paints, etc.

  Software that controls the operation of the transducer is programmed to predict grid crossings within certain predetermined tolerance limits. If this intersection does not occur within these limits, the ultrasonic energy in the transducer member is blocked. If some positional error occurs, the ultrasonic energy in the transducer member is blocked. The practitioner therefore finds the problem and then restarts the procedure at a known restart point.

  If the data is to be compared with many treatments, a grid according to the principles of the present invention can still be reapplied at the same location. The reapplication of the grid can be accomplished by first realizing that the grid is on the surface of a complex shape (berry button) rather than an orthogonal coordinate system projected onto a plane.

  After removing the hair, a transparent photosensitive paint is applied to the skin. Sensitivity is not as high as clear photographic emulsions, and is sensitive to only one color (ie, purple, the highest energy end of the visible spectrum). The camera scans the skin surface and records irregularities within 100 ms (a period that is short enough that patient motion is negligible). A resolution of 200 lines / inch should be sufficient. A 10 × 20 inch (25 × 50 cm) area requires 2,000 × 4,000 pixels. The second scan projects the grid onto the skin surface. The grid is then colored and fixed. The fixing is applied to the grid so that the grid is not cleaned but disappears in about one day. Alternatively, the grid can be removed by washing the grid with a specific solution immediately after the treatment procedure.

  The resulting grid provides coordinates and procedures for recording ultrasound image data to obtain fat thickness.

  Upon returning to the patient, the patient is applied and again photographed. Skin irregularities are cross-corrected into previously formed image files, and warp guards are created and projected. By warping, the grid is projected to the same skin location as the previous grid. For example, current Pentium® processors require approximately 30 seconds to cross correct. However, in a fixed algorithm, there is a Xilinx chip that has up to 800 times / accumulating member 100 times better than Pentium (registered trademark). This allows the warped grid to be calculated in approximately 30 ms (fast enough for projection of the grid before patient motion). The grid is fixed and the following procedure can be performed.

  In another alternative embodiment, the position of the transducer is determined using a grid having encoded positions. Thus, the grid in an embodiment of the present invention encompasses the absolute position encoded therein. A relative motion sensor is then adapted to detect the position without measuring the motion. The grid is like an orthogonal barcode. “Thick” grid lines indicate “1” and “thin” grid lines indicate “0”. The grid lines are close to each other as needed (for example, 1 line / mm).

  In another embodiment of the encoded grid method, a pseudo-random array is used. At 1 mm intervals, 512 lines cover 50 × 50 cm. Each group of nine continuous lines provides a unique code. In other words, if the transducer moves in both directions 1 cm, the relative motion sensor picks up the absolute position of the transducer. The probe then tracks along the grid on an absolute basis.

  In yet another alternative embodiment, the position of the transducer is determined without using a grid. More specifically, and of course in standard NTSC television, the frame takes 33 ms, the cross correction takes 30 ms, and the grid can be eliminated altogether. Camera chips that are available at 0.5 x 0.5 inches are used in embodiments of the present invention. The present invention contemplates mounting the camera chip on the transducer and coupling directly to the skin through the fiber optic faceplate. The skin is imaged at 1 mil resolution and the decision process is unique when each 0.5 x 0.5 inch square skin is viewed at 1 mil x 1 mil Observe. Otherwise, a larger camera chip is demonstrated with the tapered fiber optic bundle and / or a search for relative motion sensor references that are local rather than globally known at the end (eg, 1/30). Based on movement from a position a second ago.

  Regardless of whether the actual grid is used on the skin or whether advisory is used for positioning, the virtual grid is resident on the computer. This virtual grid provides coordinates for all treatment records.

  A grid having an area of 50 cm × 50 cm with a resolution of 0.2 mm includes 6.25 million grid crossing lines. The grid is suitable enough to preserve a sonogram in three dimensions from a 10 MHz ultrasound B-scan of a linear array.

  Image evaluation is collected at either end of the imaging transducer with one or two fiber optic cross-correction systems or grid sensor systems. Echoes occur on a theoretical plane that passes through the axis of the transducer face. This virtual grid is unsuitable for orthogonal grids as well as grids that are “glued” to the skin surface.

  Prior to the present invention, there was no technique for observing such HIFU when it was generated. There are several systems that sonicate using a HIFU with an on / off sequence. The imaging system is then activated during sonication. The prior art system provided an image for a few seconds or longer after the wound was generated. Furthermore, there was no technique for observing the generation of multiple HIFU wounds if they were not in the same right-angle plane.

The basis of conventional ultrasound medical imaging arrays involves generating controlled shaped pulses in tissue and detecting and processing echoes. As shown, conventionally, as shown in FIG. 9, pulses are transmitted using one member and received by another, which may include a transmission member 91. In order to find the gray scale at any xy position (ie, any pixel), the delay time T _d1 of each receiving member 92 is set such that T _t + T _n + T _dl = T _c . Here, T _t is a transmission time, and T _n is a reception time that is a constant of the pixel. Then, the sum of all received signals at that time T _c is sampled. The gray scale for that pixel is monotonically related to the absolute value of the voltage. There are many variations on the details of how this process is performed, which are well known to those skilled in the art. All of these variations using a known pulse travel time are formed from the transmission member (s) for the pixel and then to the receiving member from this pixel, and echo is scattered from that pixel. Decide if.

  However, in accordance with the principles of the present invention, the sound produced by the wound can be used to either monitor the wound production or to image the wound production so that the HIFU dose can be controlled. The present invention allows multiple wounds to be monitored or imaged independently.

  The present invention generates an image from sound generated at pixel locations. The sound need not be in a pulse or any particular form, i.e. the sound may be incoherent. In the present invention, sound can be generated by the collapse of a cavitation bubble or the boiling of the liquid produced near the focus of the HIFU beam. The present invention does not look for changes in the tissue scatter properties produced by the HIFU system, but looks for the HIFU procedure itself.

  Further, using ultrasonic Doppler technology, the present invention monitors turbulence caused by cavitation bubble growth or liquid boiling for use in determining how force is applied to the transducer during HIFU treatment. Have the ability. This is described in more detail below.

An imaging system according to the principles of the present invention is illustrated in FIG. The presence of the sound generator 101 (ie, cavitation or boiling activity) is determined by setting the delay to be the signal T _n + T _dl = T _c (a constant for that pixel) at the pixel location P. This signal is summed and detected using its RMS value. This detected signal is then averaged using a low pass filter or integrator over some arbitrary time. The output voltage represents the sound generated at that pixel. If there is sound from some other location, the signal going to the summing machine is of random phase. Random phase signals include signals such that at any moment, some voltage is positive, some voltage is negative, and the average is zero.

  Three types of sound that can be detected from pixels generated by the HIFU include the following: scatter, cavitation, and boiling from HIFU sonic generation. HIFU sound wave generation is at a certain frequency, f. Occasionally there is some energy in this harmonic (ie nf frequency, where n is an integer). Cavitation occurs at subharmonics (ie, f / n). Boiling produces sound over a broad spectrum. These are illustrated in the spectrum shown in FIG. FIG. 12 shows how this signal can be decomposed into three channels. Thus, all three sounds can be processed in the image. The invention further relates to cavitation and boiling. Thus, high pass power associated with HIFU sound wave generation is ignored.

  The HIFU transducer is surrounded by a circular or rectangular array, depending on the shape of the HIFU transducer of the receiving element. When sound is generated at a location in adipose tissue, the wave reaches each element, except at different times, depending on the distance between the transducer and the receiving element. Adding a delay line to each element aligns all received signals from a particular pixel in time and adds their amplitudes. If the sound originates from a particular treatment point, the amplitude is large, but if the sound originates from some other point, its phase is random and the amplitude is small. The fundamental difference between this and pulsed reverberant ultrasound is that in a pulsed reverberation system, the signal from each piezoelectric element of the transducer is sampled at a time for each pixel, while in the present invention the data for each pixel is Is collected continuously in each element. Therefore, several hundred receiving elements are required. If 300 are required, 300 delay lines are required for each. If the image is made in the local plane of the HIFU transducer, it can be 300 × 300 pixels. This results in 27 million delay line taps. Furthermore, the image should be created in a plane above the local point and below the local point.

When many signals of the same frequency but different amplitude and phase are added, the present invention is implemented using the fact that the sum results in a signal of the same frequency of the same amplitude and phase. obtain. In particular,
Σ _i A _i sin (ωτ + θ _i ) = Bsin (ωτ + θ)
Here, B ² = (Σ _i A _i cos θ _i ) ² + (Σ _i A _i sin θ _i ) ²
Then, θ = tan ⁻¹ ((Σ _i A _i sin θ _I ) / (Σ _i A _i cos θ _I )).

The phase and amplitude can be determined directly for each transducer from the sine component (s _i ) and cosine component (c _i ) of the Fourier transform. In particular,
θ _i = tan ⁻¹ (s _i / c _i )
And A _i ² = c _i ² + s _i ² .

  Time shift is achieved by adding a constant to the phase.

  When considering the acoustics caused by cavitation, FIG. 11 shows that the spectrum includes f / 2 and f / 3 frequencies. These two spectra are used to form two images. The received signal is digitized at twice the HIFU frequency. Digitizers are available at approximately $ 1.50 / channel, so a 300 digitizer costs $ 450.00. As shown in FIG. 13, the digitizer is then processed by delay lines that are hardened to extract sine and cosine transforms at the f / 2 and f / 3 frequencies. A minimum of 8 taps is required, but more will provide a narrower spectrum and slower output speed. The output speed is the digitized speed divided by the number of shifts, 2f. For example, if the HIFU frequency is 6 MHz, the signal is sampled at 12 MHz, and with a minimum of 8 taps, the conversion can be calculated at 1.5 MHz. Since there are two frequencies for each of the sine and cosine transforms, 6 Ms / s (megasamples per second) is provided. When the number of taps is increased to 64, 750 ks / s is obtained. This value may still be too much to process into an image. Therefore, an accumulator is added after the conversion to accumulate successive conversions. Cavitation foam does not appear to grow or disappear to fix. The 64 tap FETs occur at 5.3 microseconds at 6 MHz, so that the 64 accumulation takes an additional 0.3 ms. This corresponds to a signal flow of 2 meters, so that the difference in arrival time (several centimeters) between elements is comparable. Alternatively, the fact that the cavitation noise delay time for each element from one pixel is different can be ignored. This is because the signal is averaged over a time interval difference of about 100 times.

  To generate 10 image planes consisting of 100 × 100 pixel images at 2 frequencies each at a rate of 10 frames / second using a 200 element array, a DSP (digital signal processor) is used to generate 0 image planes. It is necessary to add the phase of the signal at a speed of. Alternatively, the chip can be configured for this particular task to be approximately 100 times faster than the previously mentioned DSP. Thus, more pixels, more planes, or faster frame rates are all feasible.

  When the acoustics caused by boiling, the phase of cavitation is fixed at the HIFU frequency, and the received signal takes into account the differences from considering the acoustics caused by cavitation that changes phase due only to bubble growth The frequency generated by boiling is independent of the HIFU drive frequency. In fact, the sound produced by boiling persists after the HIFU sonic generation process. Thus, it is unclear whether the phase produced by boiling remains stationary for 20 microseconds (the time it takes for the signal to travel from a nearby transducer element to a far transducer element). Another characteristic of noise from boiling is that it cannot be turned on and off as quickly as cavitation. Thus, the few image frames per second used in considering cavitation are not fast enough.

  Thus, this embodiment of the present invention selects the frequency from the hardened Fourier transform that is inconsistent with the sub-harmonics. These are monitored for some period (eg, 4 samples at 1.5 microsecond intervals). A curve is then set by these to approximate the phase at any particular time. Thus, differences due to path length differences from the pixel location to the various piezoelectric elements can be taken into account. This process is similar to the process shown in FIG. 13 with the following exceptions: 1) Fourier transform is inconsistent with HIFU sub-harmonics; 2) These transforms are long phase transforms 3) Four (not 1) transformations are saved for analysis; and 4) The phase for the sum is obtained by interpolation rather than addition.

  In accordance with one aspect of the present invention, the monitored Doppler dynamic sound caused by cavitation or boiling is used as an indicator to set the power level output by the transducer in the HIFU system for destroying adipose tissue Can be used as an indicator. Thus, the maximum power level adapted to the transducer can be automatically determined for any given material density. Thus, the total power used per procedure can be saved and the lifetime of the transducer can be extended.

  Now consider the power operation of the HIFU transducer. HIFU transducers are rarely operated at their maximum power. This maximum is set by the maximum drive voltage above which arcing occurs. Operating the HIFU transducer with this maximum drive voltage causes persistent overheating and destroys the HIFU transducer.

  In the prior art, the transducer is operated by an on / off cycle (eg, 1 second on and 4 seconds off) to facilitate cooling. Even when on, the transducer is operated below maximum power. In the above example, the average power is 20% of the peak. The transducer is not operated continuously with average power. This is because the biological effects of such manipulations are non-linear. The time / power threshold is necessary to initiate cavitation, so there is more biological damage due to the highest peak power at the same average power.

  Based on this “less is better, more is better” principle, the present invention operates the transducer at the highest peak power while maintaining the same average power to more efficiently destroy tissue. . Therefore, the maximum peak power can be used as much as possible. The ultrasonic energy is stored in the mechanical assembly and exits the transducer as a very high amplitude impact so that the transducer is peaked by the maximum peak voltage (or power) applied to the piezoelectric Deliver more power than power to increase the rate of tissue destruction. During the “on” interval in each on / off transducer operation cycle (a rate that is microseconds in duration), it is operated at maximum power by maximizing the power exiting the transducer, at the transducer element Heat generation does not conduct at this interval, and these advantages are a non-linear relationship between instantaneous power and tissue destruction.

  As shown in FIG. 14, the transducer element of the present invention comprises a piezoelectric element, alternating with a high impedance single layer 142 and a low impedance single layer 141 attached thereto, respectively. By transmitting pulses from the piezoelectric element to this assembly, an output is produced and the peak intensity produced by the piezoelectricity results in a lower peak power drain. Thus, the present invention includes the steps of transmitting a pulse to the assembly and recording the outflow pulse at the focal point. The transducer is then supplied with an outflow pulse in a time reversal format, allowing a very high amplitude impact to exit the assembly.

  For example, a full power impact is applied to the transducer and the generated signal exits the assembly with a peak power of only 10% of the impact. This ringing signal is then digitally recorded and performed in reverse order using a digital to analog signal transducer to generate a signal. This signal is then applied to the transducer with the peak intensity enabled by the arcing criteria. The output pulse then has a peak power of 10 × peak power initially applied by the transducer.

  In accordance with one aspect of the present invention, the application of a reduced power level, followed by the application of a peak power level to the transducer, can be triggered by the sound generated by the HIFU system that is indicative of the onset of cavitation. An acoustic signature that is indicative of the onset of cavitation or boiling can be determined using Doppler imaging techniques. Thus, the lifetime of the transducer can be extended by reducing the amount of time that the transducer is operated at peak power in an automatic manner for any given material density being treated.

  It will be apparent to those skilled in the art that various modifications and variations can be made in the present invention without departing from the spirit and scope of the invention. Accordingly, the present invention is intended to embrace modifications and variations of this invention, which are within the scope of the appended claims and equivalents.

FIG. 1 illustrates a mapping system according to the principles of the present invention. FIG. 2 shows a schematic diagram of an exemplary transducer element including an optical system according to one aspect of the present invention. FIG. 3 shows the transducer depth of transducer elements used in accordance with the present invention with different focal points and using different frequencies. 4A-4C show bottom views of an exemplary transducer according to the principles of the present invention. FIGS. 5A and 5B show the relationship between the tissue kill zone and focal length of the transducer element. FIG. 6 shows the pattern of piezoelectric elements in the transducer assembly. FIG. 6A shows the correlation between transducer elements and tissue destruction along the transducer scan direction. FIG. 6B shows the correlation between transducer elements and tissue destruction along the transducer scan direction. FIG. 7 illustrates a Fresnel lens according to the principles of the present invention. FIG. 8 illustrates a Fresnel lens according to the principles of the present invention. FIG. 9 shows a HIFU damage imaging system. FIG. 10 illustrates a HIFU damage imaging system according to the principles of the present invention. FIG. 11 shows the relative frequency / amplitude correlation between cavitation frequency, boiling frequency, and ensonization frequency. FIG. 12 shows the signal received from receiving a broken element for analysis. FIG. 13 shows a schematic diagram of a digitizer configured to extract a deformed frequency. FIG. 14 illustrates a transducer element according to the principles of the present invention. FIG. 15 illustrates various transducer assemblies according to the principles of the present invention. FIG. 16 illustrates various transducer assemblies according to the principles of the present invention. FIG. 17 illustrates various transducer assemblies according to the principles of the present invention.

Claims (46)

High-intensity focused ultrasound transducer, the following:
Boiling sensor;
A cavity sensor; and a plurality of transducer elements connected to the boiling sensor and the cavity sensor;
A high-intensity focused ultrasound transducer. The high intensity focused ultrasound transducer of claim 1, wherein the amount of energy emitted by each of the plurality of transducer elements is controlled by measurements taken by the cavitation and boiling sensors. The high intensity focused ultrasound transducer of claim 1, further comprising an optical sensor, wherein at least one of the position, velocity, and rotation of each of the plurality of transducer elements comprises the optical sensor. High-intensity focused ultrasound transducer, determined using. The high intensity focused ultrasound transformer of claim 3, wherein the optical sensor is responsive to an orthogonal barcode grating, the orthogonal barcode grating comprising a pseudo-random array printed on a patient's body. Deucer. The high intensity focused ultrasound transducer of claim 1, further comprising a ball and socket sensor, wherein at least one of the position, velocity, and rotation of each of the plurality of transducer elements is the ball and A high intensity focused ultrasound transducer, determined using a socket sensor. The high intensity focused ultrasound transducer of claim 1 further comprising an optical sensor, wherein information regarding treatment energy to be applied by each of the plurality of transducer elements is obtained using the optical sensor. High intensity focused ultrasound transducer to be determined. 7. The high intensity focused ultrasound transducer of claim 6, wherein the plurality of transducers connected to the transducer element for receiving ultrasound energy from the transducer, indicating the coverage of the transducer over a region. A high-intensity focused ultrasound transducer, further comprising: The high intensity focused ultrasound transducer of claim 7, wherein the plurality of LEDs are responsive to a dye applied to a patient's body. The high intensity focused ultrasonic transducer of claim 1, further comprising an ultrasonic sensor, wherein a position of each of the plurality of transducer elements is determined using the ultrasonic sensor. Focused ultrasonic transducer. The high intensity focused ultrasound transducer of claim 1, further comprising an ultrasound sensor, wherein information regarding treatment energy to be applied by each of the plurality of transducer elements uses the ultrasound sensor. A high-intensity focused ultrasound transducer. The high intensity focused ultrasound transducer of claim 1, wherein each of the transducer elements is:
A Fresnel lens comprising: a piezoelectric element; and at least two materials connected to the piezoelectric element;
A high-intensity focused ultrasound transducer. The high intensity focused ultrasound transducer of claim 1, wherein the transducer comprises a solid plastic material for separating the transducer from organ tissue. The high intensity focused ultrasound transducer of claim 1, wherein each of the transducer elements comprises a mechanical modulator for generating a plurality of energy beams. The high intensity focused ultrasonic transducer of claim 1, wherein each of the transducer elements comprises a single crystal piezoceramic element. The high-intensity focused ultrasound transducer according to claim 1,
A high intensity focused ultrasound transducer, wherein each of the transducer elements can generate a plurality of rays; and each of the transducer elements is operable independently of each other. The high intensity focused ultrasound transducer of claim 1, wherein the transducer is capable of emitting two rays of different frequencies simultaneously for a single spot. The high-intensity focused ultrasound transducer of claim 1, wherein the plurality of transducer elements are arranged in a pattern that generates a random ray path. The high intensity focused ultrasound transducer of claim 1, further comprising an A-trace sensor for measuring fat thickness. The high intensity focused ultrasound transducer of claim 1, wherein the position of the transducer is determined according to virtual data comprising patient body data stored in a computer. A high intensity focused ultrasound transducer assembly comprising:
One or more transducer elements; and a plurality of motion and tissue sensors, wherein the high intensity focused ultrasound transducer can be manually operated;
A high intensity focused ultrasound transducer assembly comprising: Passive imaging device, the following:
A plurality of sensors adapted to detect sound generated by cavitation or boiling of the organ tissue; and a display device adapted to display an image corresponding to the sound detected by the plurality of sensors ,
A passive imaging device comprising: A method of applying ultrasonic energy to organ tissue, the method comprising:
Radiating ultrasonic energy from the transducer to the organ tissue in a series of on / off cycles, so that the heat generated during the radiation is transmitted during successive on cycles in the series of on / off cycles , Not conducted from the transducer, process,
Including the method. 23. The method of applying ultrasonic energy according to claim 22, wherein the transducer is operated at peak power while maintaining average power. 23. The method of applying ultrasonic energy according to claim 22, wherein the transducer is cooled by air cooling. A method for identifying adipose tissue to be removed from a patient, comprising:
Imaging a patient using a linear array of optical cameras and an ultrasound imaging system to mark a contour of constant fat thickness;
Creating a skin fingerprint by printing an image from the imaging process; and identifying the fat thickness of the individual using different color inks;
Including the method. A system for the destruction of adipose tissue utilizing high intensity focused ultrasound (HIFU) within a patient's body, the system comprising:
Controller for electrical storage of data and control of multiple system components;
A means for mapping a human body to establish three-dimensional coordinate position data for existing adipose tissue within the human, wherein the controller identifies a plurality of adipose tissue positions on the human body And can establish a protocol for adipose tissue destruction; means;
A transducer assembly having one or more piezoelectric elements for emitting high intensity focused ultrasound and at least one sensor, the sensor for safe operation of the one or more piezoelectric elements, A transducer assembly that provides feedback information to the controller;
With
Here, the at least one sensor is electrically connected to the controller, and the controller is required for the one or more piezoelectric elements based on positioning information obtained from the three-dimensional coordinate position data. A system that provides treatment instruction information. 27. The system of claim 26, further comprising a treatment table, wherein the treatment table has a plurality of fixed identifiable positions present in the table, whereby the mapping component is the fixed table. A system that can identify the relative position of the human body on the table by using the identified identifiable position. 28. The system of claim 27, wherein the fixed identifiable position is a plurality of electrical or magnetic position markers. 27. The system of claim 26, further comprising the gantry having a three-dimensional range of movement with respect to the patient's body, such that one or more of the components of the system are operable using the gantry. The transducer assembly further includes:
Boiling sensor;
A cavity sensor; and one or more piezoelectric elements connected to the boiling sensor and the cavity sensor;
27. The system of claim 26, comprising: 27. The system of claim 26, wherein the amount of energy released by each of the piezoelectric elements is controlled by measurements taken by the cavitation sensor and the boiling sensor. 27. The system of claim 26, further comprising an optical sensor, wherein at least one of position, velocity, and rotation of the one or more piezoelectric elements is determined using the optical sensor. . 35. The system of claim 32, wherein the optical sensor is responsive to an orthogonal barcode grid, the orthogonal barcode grid comprising a pseudo-random array printed on the patient's body. 27. The system of claim 26, further comprising a ball and socket sensor, wherein at least one of position, velocity, and rotation of the one or more piezoelectric elements is determined using the ball and socket sensor. System. 27. The system of claim 26, further comprising an optical sensor, wherein information regarding treatment energy applied by each of the one or more piezoelectric elements is determined using the optical sensor. 36. The system of claim 35, further comprising a plurality of LEDs connected to the transducer assembly for indicating coverage of the transducer assembly over a region that receives ultrasonic energy from the one or more piezoelectric elements. .   40. The system of claim 36, wherein the plurality of LEDs are responsive to dye applied to the patient's body. 27. The system of claim 26, further comprising an ultrasonic sensor, wherein the position of each of the one or more piezoelectric elements is determined using the ultrasonic sensor. 27. The system of claim 26, further comprising an imaging ultrasonic sensor, wherein information regarding treatment energy applied by each of the one or more piezoelectric elements is determined using the imaging ultrasonic sensor. System. 27. The system of claim 26, wherein each of the one or more piezoelectric elements comprises a Fresnel lens connected to the piezoelectric element, the Fresnel lens comprising at least two materials. 27. The system of claim 26, wherein each of the one or more piezoelectric elements comprises a mechanical modulator that generates a plurality of energy beams. 27. The system of claim 26, wherein each of the one or more piezoelectric elements can generate a plurality of beams; and the one or more piezoelectric elements are operable independently of each other. 27. The system of claim 26, wherein the transducer assembly can simultaneously emit two or more HIFU beams of different frequencies for a single spot. 27. The system of claim 26, wherein the one or more piezoelectric elements are arranged in a pattern that generates a random ray path. 27. The system of claim 26, further comprising an A-trace sensor for measuring fat thickness. 27. The system of claim 26, wherein the position of the transducer assembly is determined according to a virtual grid that includes patient body data stored in a computer.

Images